Classification of Medicines as ‘Pharmacy only’ and ‘General Sales’

Amanda Williams edqm Expert Workshop 21 November 2014

University of Surrey

Overview

• Introduction

• OTC Medicines classification in Europe

• Classification of OTC medicines in UK

• General sales list products

• Impact on work of Committee of Experts on Legal Classification

Healthcare delivery in Europe

• Variability: – Medical practice – Pharmacy practice – OTC availability – OTC medicines – Reimbursement

policy – Consumer attitude

and expectations

OTC medicines classification in Europe Legal Classification governs Modes of Supply

• from pharmacies only, under the supervision of a pharmacist, e.g. Austria, France

• in a pharmacy, on self-selection where the pharmacist does not have to be involved in the purchase, e.g. Germany, Norway, Sweden, Lithuania

• outside pharmacies, but requiring a qualified medicines advisor to be present e.g. a druggist in the Netherlands

• outside pharmacies and with no professional supervision i.e. general

sales supply as in the UK

4

OTC Legal Classification in UK

• P Pharmacy availability - under the supervision of a pharmacist

• GSL General Sale List

- general retail outlets, e.g. petrol stations

P + GSL = Over-the-counter (OTC), non-prescription

GSL Criterion UK

Medicines which can with reasonable safety be sold or supplied otherwise than by or under the supervision of a pharmacist. • “With reasonable safety” may apply in circumstances

where: – the hazard to health, – the risk of misuse, or – the need to take special precautions in handling are

small, and • where wider sale would be a convenience to the

purchaser.

UK perspectives on OTC

• Empowering patients to make informed choices in prevention, self diagnosis and treatment of disease and disability

• Broadening patient choice through widening access to medicines, including through reclassification where it is safe to do so

• Making best use of pharmacists' expertise • Making better use of GP, and urgent and

emergency care services

UK GSL Products - Self limiting conditions

• Acne • Bites and stings • Cold • Cold sores • Constipation • Diarrhoea • Fever • Flu symptoms • Haemorrhoids • Hayfever treatment and

prevention • Headache

• Indigestion/heartburn • Male pattern baldness • Mild to moderate pain • Minor cuts and bruises • Mouth ulcer • Smoking cessation • Sore throat

Products only for Pharmacy supply in UK

• Codeine containing analgesics • Pseudoephedrine decongestant • Azithromycin for Chlamydia • Chloramphenicol eye drops/ ointment • Sedating antihistamines

9

Nicotine Replacement Therapy

• Smoking is the biggest public health target in the UK

• There are no circumstances

in which it is safer to smoke than to use NRT

• Widest possible availability, in

a variety of forms, for a range of patient populations, is key to achieving the greatest positive impact on public health

GSL Pros and Cons

Convenience for patient • Numbers of outlets • Longer opening hours • Location, especially in rural areas • Self service (empowering) • Lack of professional advice • Less choice

11

Pack label for safe use (+ website)

Label Warning

Being overweight increases your risk of developing several serious health problems such as diabetes and heart disease. You should see your doctor for a check-up.

Committee of Experts on the Classification of Medicines

Current work includes • Consideration on the classification of medicines • Prescription and non prescription

Proposal to expand non-prescription • Pharmacy only • General sales

Participants views welcome

14